Washington- Kit Check, the leader in automated medication management solutions for hospitals, today announced the acceptance of their pilot program that includes partnerships with leading pharmaceutical organizations and health systems to the Drug Supply Chain Security Act (DSCSA) from the Food and Drug Administration (FDA). The focused pilot will enhance requirements for package-level tracing and verification and explore RFID as an alternative data carrier to the 2D barcode. The program, which includes efforts from Hackensack University Medical Center, Coral Gables Hospital, Nephron Pharmaceuticals and Sandoz, a Novartis division.
“There are powerful technologies operating today, such as RFID, that can significantly improve our industry operations further. We are confident our pilot will shine light on the impact RFID can have on the drug supply chain for years to come and become a standard practice amongst all stakeholders.”
The goal of this pilot is to demonstrate how an RFID data carrier for electronic data exchanges can bring interoperability and tracking improvements while lowering the costs associated with DSCSA compliance. With RFID technologies in place, all parties involved will be able to exchange product tracing information across the pharmaceutical distribution supply chain, while identifying, managing, and preventing the distribution of suspect and illegitimate products.
“Since the implementation of DSCSA in 2015, the FDA has made impressive strides to improve the safety and security of the drug supply chain,” said Lou Kennedy, chief executive officer, Nephron. “There are powerful technologies operating today, such as RFID, that can significantly improve our industry operations further. We are confident our pilot will shine light on the impact RFID can have on the drug supply chain for years to come and become a standard practice amongst all stakeholders.”
The pilot will leverage existing 2D barcode monitoring technology and RFID so both methods can be evaluated and analyzed. This will allow participants to show the areas for growth from the existing technologies, while expanding the use cases and supporting data for RFID. The labels and markers will be included on a range of injectable drugs in vials and pre-filled syringes that meet the definitions laid out by the FDA – following their journey from manufacturing through the hospital.
“The DSCSA’s pilot program is intended to assist drug supply chain stakeholders, including the FDA, to find innovative technologies that can help track drugs that are distributed throughout the county. This is of the utmost importance given the opioid epidemic and growing impact of drug diversion in hospitals,” said Kevin MacDonald, CEO and co-founder of Kit Check. “We are thrilled to partner with these forward-thinking organizations that understand investing in next-generation technology solutions will make an impact on the way drugs are distributed across the U.S.”
The program is scheduled to last six months. Upon conclusion, the FDA will make the final reports public alongside other DSCSA 2023 participants’ findings, with the hope that all supply chain stakeholders can benefit from the data. To learn more about the DSCSA please visit the FDA website at www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa. Additionally, a full list of FDA accepted pilot programs can be found here: https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/dscsa-pilot-project-program.
About Kit Check™
Kit Check is the leading provider of automated medication management solutions for hospital pharmacies. Our solutions blend powerful machine learning and advanced tracking technology to streamline medication inventory, workflow, and auditing processes and help hospital pharmacies cut costs, reduce risk, and get more done. To date, our more than 500 U.S. and Canadian hospital partners have tracked over 50 million medications using the Kit Check and Bluesight™ for Controlled Substances software. More information about Kit Check and our software solutions can be found at kitcheck.com.